WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / June 2026 / K261023

510(k) cleared

Microdacyn Wound Irrigation Solution

Sonoma Pharmaceuticals, Inc. · Jun 24, 2026 · K261023

FDA cleared the Microdacyn Wound Irrigation Solution from Sonoma Pharmaceuticals, Inc. on Jun 24, 2026 under K261023, a traditional 510(k). The device falls under product code FRO, Dressing, Wound, Drug as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Mar 30, 2026. The decision came 86 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Sonoma Pharmaceuticals, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261023?

K261023 is the FDA 510(k) for Microdacyn Wound Irrigation Solution, submitted by Sonoma Pharmaceuticals, Inc.. FDA's decision date was Jun 24, 2026, under product code FRO (Dressing, Wound, Drug).

Who makes the Microdacyn Wound Irrigation Solution?

Sonoma Pharmaceuticals, Inc., based in Boulder, CO, is the applicant of record for K261023.

How long did the K261023 review take?

FDA received the submission on Mar 30, 2026 and issued its decision on Jun 24, 2026, 86 days later.

← All decisions in June 2026